FDA (510) clearances, by definition, are not usually considered “ground-breaking.” Such lofty language is usually saved for the rare FDA PMA (premarket approval) approved product. But Zimmer Biomet Holdings, Inc., used such language on February 11, 2016, to describe its recently FDA cleared foot and ankle joint fusion system, called the Unite3D Bridge Fixation System.
Zimmer’s “Groundbreaking” Foot and Ankle Fusion System
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Why the hype?
Zimmer says the system replaces traditional surgical plates, screws and staples with a 3D printing and OsseoTi porous metal technology designed to offer greater stability than previous systems. The system features the company’s proprietary OsseoTi porous metal technology, which, the company says, mimics the architecture of cancellous bone. The system also includes an osteoconductive matrix designed to provide for biological incorporation.
Zimmer Biomet collaborated with orthopedic surgeons Greg Pomeroy, M.D., of New England Foot and Ankle Specialists and John Early, M.D. of Texas Orthopaedic Associates.
Early said that by offering foot and ankle surgeons a construct for osseointegration across the entire fusion site, Zimmer’s new system, “provides a stable and durable solution for fracture and osteotomy fixation and joint arthrodesis within the midfoot and hindfoot. Having replaced the plates, screws and surgical staples of traditional foot and ankle fusion, we also wanted to offer the intraoperative benefits of a streamlined procedure with easy-to-use and disposable surgical instruments.”
In addition to osseointegration, the company says the system is made up of a solid internal framework for added strength and rigidity and features a zero-prominence design and uniform compression along the entire length of the implant. Nine implant size options and single-use surgical instrumentation is included in order to address a wide spectrum of patient anatomy and clinical situations.
“The Unite3D Bridge Fixation System is unlike anything in our portfolio, and we are proud to commercialize a true innovation in this exciting clinical area, ” said Ben Joseph, Zimmer’s foot and ankle general manager. “This powerful combination of 3D printing technology and our OsseoTi porous metal material is only the latest contribution from Zimmer Biomet’s robust innovation pipeline. We aim to serve the unique needs of patients and surgeons while expanding our presence in every category of musculoskeletal healthcare, including the rapidly growing market of foot and ankle treatments.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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